NEW YORK (1010 WINS) -- Two more drug manufacturers have recalled the widely-used Type 2 diabetes medication metformin, over concerns that it contains too much of the human carcinogen NDMA, a "probable" cancer-causing substance, the FDA announced this week.
The two new recalls follow similar recalls in May from Teva Pharmaceuticals, Marksans Pharma Limited, Apotox Corp. and Amneal Pharmaceuticals.
This week, Lupin Pharmaceuticals Inc. issued the recall for all of its batches of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg. According to the FDA, "additional analysis revealed that certain tested batches were above the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA)."
Another drug maker, Granules Pharmaceuticals, Inc., has recalled 12 lots of its Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count.
Metformin is a prescription medication that is used “to improve blood glucose control in adults with Type 2 diabetes mellitus,” the FDA said. Patients who are currently taking the medication should contact their medical providers before they stop, as stopping suddenly could be dangerous to those with serious conditions, the FDA noted.
LUPIN PHARMACEUTICALS Metformin Hydrochloride Extended-Release Tablets USP
500 mg, NDC No. 68180-338-01, distributed between Nov. 21, 2018, and May 27, 2020.
1000 mg, NDC No. 68180-339-09, distributed between Nov. 21, 2018, and May 27, 2020.
500 mg, NDC No. 68180-336-07, distributed between Nov. 5, 2018, and May 22, 2020.
1000 mg, NDC No. 68180-337-07, distributed between Nov. 5, 2018, and May 22, 2020.
The medication was distributed in bottles of 60, 90 and 100 tablets and was distributed nationwide in the United States to wholesalers, distributors, drug chain, mail order pharmacies and supermarkets.
For more information, call Inmar Rx Solutions, Inc. at 855-532-1856, between 9 a.m. and 5 p.m. EST, weekdays.
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg
100 count bottles, NDC No. 70010-492-01, Lot numbers and expiration dates - 4920003A/May 2021, 4920004A/June 2021, 4920005A/June 2021, 4920009A/November 2021, 4920010A/May 2022, 4920011A/June 2022, 4920012A/June 2022, 4920013A/July 2022, 4920014A/July 2022, 4920015A/August 2022 and 4920016A/January 2023.
500 count bottles, NDC No. 70010-492-05, lot No. 4920005B, expires June 2021.